The Effects of Probiotics in Atopic Dermatitis - Full Text View

Sponsors and Collaborators:	University of California, Los Angeles Thrasher Research Fund
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00378300

Purpose

The purpose of this study is to study the clinical effects of taking probiotics in patients who have moderate to severe atopic dermatitis. There has been several studies showing improvement in the severity of atopic dermatitis after taking probiotics. The mechanism of this improvement is currently unknown. We propose that probiotics improve atopic dermatitis by stimulating, or increasing, the activity of a special type of cell called the T Regulatory cell--which can suppress the activity of allergic disease.

Condition	Intervention
Atopic Dermatitis	Drug: Oral Probiotics

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Probiotics Ameliorate Atopic Dermatitis by Induction of T Regulatory Cells

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

SCORAD Score change taken at baseline and after 1 month of either probiotic or placebo
T Regulatory cell activity change taken at baseline and after 1 month of either probiotic or placebo

Secondary Outcome Measures:

Dermatitis Family Impact Questionnaire change taken at baseline and after 1 month of either probiotic or placebo
T Regulatory cell activity when exposed to probiotics in vitro
Change in Serum IgE or IgG levels taken at baseline and after 1 month of either probiotic or placebo

Estimated Enrollment:	56
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The central hypothesis of this study is that a subset of commercially available probiotic formulations will ameliorate moderate to severe atopic dermatitis in children by inducing the development of T Regulatory (Treg) cells. We specifically hypothesize that the probiotic mixture that induces Treg activity in vitro, will also improve the severity of atopic dermatitis in a specific patient by inducing Treg activity in vivo.

We will determine whether probiotic mixtures are better able to ameliorate the severity of atopic dermatitis when compared to patients treated with placebo. We will conduct a 4-week randomized, double-blind, placebo controlled clinical trial designed to evaluate the efficacy of probiotics in reducing the clinical severity of atopic dermatitis as assessed by our primary outcome measure, the SCORing Atopic Dermatitis (SCORAD) index. We specifically hypothesize that probiotics will clinically improve the disease.
We will assess whether probiotic mixtures induce the development of T regulatory cells in patients with atopic dermatitis.

A. We will measure the relative levels of Tregs in peripheral blood before and after probiotic or placebo administration in order to assess whether the probiotic mixtures alter Treg development in vivo, and whether these changes correlate with improvement in clinical scores. Primary outcomes will be measurements of gene expression and absolute increases in cell population. We specifically hypothesize that probiotics will increase Treg activity.

B. We will also determine if all patients' Tregs have in vitro responses to probiotics. This data will be used to correlate whether clinical responders in the study also have strong in vitro responses.

Eligibility

Ages Eligible for Study:	6 Months to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age between 6 months to 3 years
Physician diagnosis of moderate to severe atopic dermatitis as defined by the Hanifin and Rajka criteria
Ability to take enterally commercially available probiotics by powder form added to food or drink
Ability to undergo venipuncture or dermal puncture (if less than 1 year old)

Exclusion Criteria:

Prior exposure to probiotics
Current antibiotic administration
Known history of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency
Absence of T regulatory cell induction by probiotic bacteria on initial laboratory assessment
Any other condition in which the Investigators involved in the study determine potential subject is unsuitable for the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378300

Locations

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

Thrasher Research Fund

Investigators

Principal Investigator:	Michael H Land, MD	University of California, Los Angeles
Principal Investigator:	Martin G Martin, MD, MPP	University of California, Los Angeles
Principal Investigator:	Robert L Roberts, MD, PhD	University of California, Los Angeles
Study Director:	Tatiana Hernandez	University of California, Los Angeles

More Information

Publications:

Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9.

Isolauri E, Arvola T, Sutas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000 Nov;30(11):1604-10.

Pessi T, Sutas Y, Hurme M, Isolauri E. Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000 Dec;30(12):1804-8.

Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71.

Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. J Allergy Clin Immunol. 2003 Feb;111(2):389-95.

Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis: a randomised controlled trial. Arch Dis Child. 2005 Sep;90(9):892-7. Epub 2005 Apr 29.

Viljanen M, Savilahti E, Haahtela T, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Kuitunen M. Probiotics in the treatment of atopic eczema/dermatitis syndrome in infants: a double-blind placebo-controlled trial. Allergy. 2005 Apr;60(4):494-500.

Smits HH, Engering A, van der Kleij D, de Jong EC, Schipper K, van Capel TM, Zaat BA, Yazdanbakhsh M, Wierenga EA, van Kooyk Y, Kapsenberg ML. Selective probiotic bacteria induce IL-10-producing regulatory T cells in vitro by modulating dendritic cell function through dendritic cell-specific intercellular adhesion molecule 3-grabbing nonintegrin. J Allergy Clin Immunol. 2005 Jun;115(6):1260-7.

Responsible Party:	UCLA Medical Center ( Michael Land )
Study ID Numbers:	06-08-007-01
Study First Received:	September 18, 2006
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00378300 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

Atopic Dermatitis
Probiotics
T Regulatory Cells

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009